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临床试验/NCT05668845
NCT05668845已完成不适用

Paragastric Autonomic Neural Blockade as Part of Combined Anesthesia. Impact on Anesthetic Agents Consumption: A Randomized Clinical Trial Protocol

Universidad Simón Bolívar2 个研究点 分布在 1 个国家目标入组 79 人开始时间: 2023年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
79
试验地点
2
主要终点
Intraoperative consumption of the halogenated agent (sevoflurane)

研究概览

简要总结

To evaluate the effect of early autonomic blockade on the consumption of remifentanil and halogenated anesthesia in the intraoperative period during laparoscopic sleeve gastrectomy.

详细描述

Balanced general anesthesia, even if combined with local anesthesia or parietal blocks such as transversus abdominis plane (TAP), subcostal, or pararectal blocks, is insufficient to block the autonomic impulses released during most intra-abdominal visceral surgeries, especially in laparoscopic sleeve gastrectomy (LSG). These impulses are, in part, responsible for the hemodynamic changes observed during different phases of LSG and the subsequent visceral pain and associated symptoms, such as nausea and vomiting, observed in a substantial number of patients in the immediate postoperative period after LSG and other minimally invasive procedures. Visceral pain substantially impacts patients' quality of life, recovery time, nursing time allocation, and resultant risk of opioid abuse. Nausea, food intolerance, and pain are responsible for most readmissions after LSG and other bariatric procedures. Many of these patients have associated severe respiratory impairments and other comorbidities. They often need increased amounts of halogenated anesthetics, opioid analgesics, antiemetics, and other anesthetic modalities such as epidural anesthesia. A recent randomized clinical trial (RCT) demonstrated that a novel approach, namely paragastric autonomic neural blockade (PG-ANB), is safe and effective in addressing visceral pain while reducing the need for analgesics, including opioids and the decreasing nausea and vomiting in the first 24 hours after a laparoscopic sleeve gastrectomy. In an observational series, we found that by performing PG-ANB as the first step in LSG, the need for morphine-equivalent doses and halogenated anesthetics diminished, and hemodynamic stability increased while maintaining the previously reported reduction of postoperative visceral pain and associated symptoms. Similarly, when implementing a variation of the autonomic blockade targeting proper pathways as an early step in cholecystectomy, the same beneficial effects were observed in affected patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

盲法说明

The patient and the independent investigator assessing and recording the patient's data will be blinded to treatment arm assignments.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • all adult patients scheduled for LSG at each participating institution.
  • Exclusion Criteria
  • the inability to perform a PG-ANB because of anatomical difficulties
  • the need for revisional surgery
  • the need for concomitant hiatal hernia repair or other surgical procedures
  • conversion to open surgical procedures
  • allergies to local anesthetics or medication described in the anesthesia protocol
  • intraoperative complications (e.g., visceral or vascular perforations)
  • anesthesia-related complications requiring admission to intensive care

排除标准

  • 未提供

结局指标

主要结局

Intraoperative consumption of the halogenated agent (sevoflurane)

时间窗: duration of the anesthesia

The anesthetic machine will determine the administered amount of sevoflurane (Dräger Primus) which will be reported in ml/min.

Intraoperative Remifentanil consumption

时间窗: duration of the anesthesia

The amount of remifentanil administered will be calculated based on the amount of the consumed mix and reported as total mcg and mcg/kg/min.

次要结局

  • recovery from anesthesia measured by the Modified Aldrete Scale(one hour after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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